Quality Management Systems Manager

Job Summary

Overseeing and advancing quality management systems, the remote Quality Management Systems Manager will implement an integrated electronic Quality Management System (eQMS) while ensuring compliance with cGMP standards across multiple facilities.

Key responsibilities

• Lead the evaluation and integration of a unified electronic Quality Management System (eQMS) across various sites
• Manage Document Control and Change Control processes to ensure adherence to cGMP standards
• Direct investigations and execution of Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA) through the eQMS

Required qualifications

• Bachelor's degree in chemistry, biology, bioengineering, Quality Systems, or a related scientific discipline
• 5+ years of direct experience in Quality Assurance or Quality Engineering in a cGMP environment, with 3+ years in a supervisory role
• High proficiency with Quality Management Systems (QMS) and ERP software, such as SAP
• Working knowledge of PLM/eQMS software platforms and advanced Microsoft Office Suite skills
• Master's degree, PCQI, or ASQ certification preferred